Medical Device Strategist

• Medical device consultant with both broad and deep business and clinical science expertise uniquely able to provide a 'Multifunctional Big Picture' strategy;
• Integration expert that aligns companies for success by coordinating the clinical science and business goals;
• Uses unique tools and algorithms developed from a 40-company/50-device experience to execute Multifunctional Big Picture strategy;
• Methods have repeatedly proven effective in putting companies on the 'Fast Track';
  • Solving technical and business hurdles
  • Identifying and designing around pitfalls
  • Expediting product clearance
  • Optimizing the revenue ramp
  • Obtaining funding
  • Meeting BOD milestones
• Inventor of a $100M/year revenue medical product, first ultrasonic contrast agent;
• Author of 20 White Papers yielding increased sales, venture funding, and FDA acceptance of trial endpoints and reversal of their previously stated decisions;
• Track record of 100% success with FDA.

Consulting Services

Multifunctional C-Level Expertise: Chief Executive Officer (CEO) Chief Science Officer (CSO) Chief Strategy Officer (CSO) Executive Management Multifunctional Big Picture Strategy Opportunity Assessment, Due Diligence Entrepreneur, Start-ups Fundraising, Venture Capital, Angel Turnaround, Troubleshooting Board of Directors (BOD)

Market Research Scientific Advisory Board (SAB) Research and Development (R&D) Clinical Studies, Trials Regulatory (FDA, IDE, 510(k), PMA) Intellectual property (IP), Patents Data and Statistics, Bayesian and Frequentist White Papers, Medical Writing Publications Fast Tracking